System and method for maximum insulin pump bolus override

ABSTRACT

An ambulatory infusion pump can include a maximum bolus override procedure. When a bolus amount greater than a maximum bolus amount is requested, the pump can provide an alert indicating that the amount requested exceeds the maximum bolus amount. If the user confirms the request in response to the alert, the bolus amount can be delivered to the user. The amount delivered in response to the confirmation can be a first portion of the bolus amount. A reminder can then be provided that a second portion of the bolus amount that is a remaining portion of the requested bolus amount was also requested. If a second confirmation is received in response to the alert, the second portion of the bolus amount can also delivered to the user.

RELATED APPLICATION

This application is a continuation of application Ser. No. 15/948,368,filed Apr. 9, 2018, which in turn is a continuation of application Ser.No. 13/800,387 filed Mar. 13, 2013, now U.S. Pat. No. 9,940,441, issuedApr. 10, 2018, all of which are hereby fully incorporated herein byreference.

FIELD OF THE INVENTION

The present invention is directed to pumps for the delivery of fluid,such as medicament including insulin, and, more particularly toproviding users with the flexibility to override maximum bolus limits inpumps while still retaining the safety features of maximum bolus limits.

BACKGROUND

There are many applications in academic, industrial, and medical fieldsthat benefit from devices and methods that are capable of accurately andcontrollably delivering fluids, such as liquids and gases that have abeneficial effect when administered in known and controlled quantities.Such devices and methods can be particularly useful in the medical fieldwhere treatments for many patients include the administration of a knownamount of a substance at predetermined intervals.

Insulin-injecting pumps have been developed for the administration ofinsulin for those suffering from both type I and type II diabetes. Someinsulin injecting pumps configured as portable infusion devices canprovide continuous subcutaneous insulin injection and/or infusiontherapy for the treatment of diabetes. Such therapy may include theregular and/or continuous injection or infusion of insulin into the skinof a person suffering from diabetes, and offers an alternative tomultiple daily injections of insulin by an insulin syringe or an insulinpen. Such pumps can be ambulatory/portable infusion pumps that are wornby the user and that may use replaceable cartridges. Examples of suchpumps and various features that can be associated with such pumpsinclude those disclosed in U.S. patent application Ser. No. 13/557,163,U.S. patent application Ser. No. 12/714,299, U.S. patent applicationSer. No. 12/538,018, U.S. Provisional Patent Application No. 61/655,883,U.S. Provisional Patent Application No. 61/656,967 and U.S. Pat. No.8,287,495, each of which is incorporated herein by reference.

Regulatory and other considerations require, e.g., that insulin pumpshave a maximum bolus limit that may be defined as the maximum amount ofinsulin that a user can have the pump deliver at any one time. Manypumps also enable a user to set a customized maximum bolus amount thatis less than such a limit programmed into the devices. This limitprovides a safety feature that prevents a user from inadvertently takinga bolus that is much larger than necessary and potentially unsafe. Forexample, a user intending to take a bolus of 4 units of insulin mayinadvertently enter 44 units of insulin, which could potentially causeserious health concerns for the user. Additionally, the highest level atwhich the maximum bolus limit can be set is typically the same for allusers, even though each user's needs typically are different from oneanother. For example, there may be a patient for whom a bolus amountthat is unsafe for much of the population would be perfectly acceptable,yet that patient's pump may have a programmed maximum bolus limit thatwill prevent the patient from taking such a bolus. In addition, thereare circumstances where it may be appropriate for a user to receive abolus of medicament such as insulin that is larger than the user'scustomized maximum bolus limit. For example, a user's blood sugar levelmight be much higher than normal, or the user might have consumed a muchlarger number of carbohydrates than usual. In such a circumstance, theuser's custom-set limit will prevent the user from taking such acomplete bolus, even if it is warranted.

Therefore, there is a need for a system and a method that provides forgreater flexibility in establishing, maintaining and/or changing maximumbolus limits in fluid pumps for delivery of medicament such as insulin.

SUMMARY OF THE INVENTION

An ambulatory infusion pump can include a maximum bolus overrideprocedure. When a bolus amount greater than a maximum bolus amount isrequested, the pump can provide an alert indicating that the amountrequested exceeds the maximum bolus amount. If the user confirms therequest in response to the alert, the bolus amount can be delivered tothe user. In some embodiments, following the confirmation a firstportion of the bolus amount is delivered. A reminder is then providedthat a second portion of the bolus amount that is a remaining portion ofthe requested bolus amount was also requested. If a second confirmationis received in response to the alert, the second portion of the bolusamount is also delivered to the user. In this manner, the pump providesthe flexibility to override a maximum bolus limit while retaining safetybenefits precluding accidental delivery of a larger than intended bolus.

In some embodiments, an ambulatory infusion pump includes a deliverymechanism adapted to facilitate delivery of medicament such as insulinto a user, a user interface, a memory and a processor. The memory can beadapted to store a maximum bolus limit defining a maximum bolus amount auser is allowed to enter by regulation or choice into the user interfacefor delivery by the delivery mechanism. The processor can be programmedto execute a bolus override procedure if a user requests a bolus greaterthan the maximum bolus limit. The bolus override procedure can includeproviding an alert indicating that the bolus amount requested exceedsthe maximum bolus limit. If a confirmation of the request is received inresponse to the alert, the processor can cause the delivery mechanism todeliver the requested bolus. In some embodiments, a first portion of thebolus is delivered in response to the confirmation and then theprocessor provides one or more reminders that a second portion of thebolus that can be the remainder of the requested bolus amount wasrequested. In response to a second confirmation received in response tothe reminder, the processor can cause the delivery mechanism to deliverthe second portion of the bolus amount.

Certain embodiments are described further in the following description,examples, claims, and drawings. These embodiments will become moreapparent from the following detailed description when taken inconjunction with the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an infusion pump according to anembodiment of the present invention.

FIG. 2 is a block diagram representing an embodiment of an infusionpump.

FIG. 3 depicts a screen shot of a home page screen of a graphical userinterface of an infusion pump according to an embodiment of the presentinvention.

FIG. 4 depicts a screen shot of a bolus object of a graphical userinterface of an infusion pump according to an embodiment of the presentinvention.

FIG. 5 is a flow diagram illustrating a maximum bolus override procedureaccording to an embodiment of the present invention.

FIG. 6 is a screen shot of a maximum bolus limit warning screenaccording to an embodiment of the present invention.

FIG. 7 is a screen shot of a bolus delivery reminder screen according toan embodiment of the present invention.

DETAILED DESCRIPTION

Provided herein are systems, devices and methods for overriding amaximum bolus limit in an infusion pump and particularly in an insulinpump. Some embodiments may include advances in the internal components,the control circuitry, and improvements in a user interface of thesystems and devices. The advances may allow for a safer and moreaccurate delivery of medicament to a patient than is currentlyattainable today from other devices, systems, and methods. Althoughembodiments described herein may be discussed in the context of thecontrolled delivery of insulin, delivery of other medicaments,including, for example, glucagon, pramlintide, etc., as well as otherapplications are also contemplated. Device and method embodimentsdiscussed herein may be used for pain medication, chemotherapy, ironchelation, immunoglobulin treatment, dextrose or saline IV delivery, orany other suitable indication or application. Non-medical applicationsare also contemplated.

FIG. 1 depicts an embodiment of a pump 12 such as an infusion pump thatcan include an internal pumping or delivery mechanism and reservoir fordelivering medicament such as insulin to a patient and an output/display44. The type of output/display 44 may vary as may be useful for aparticular application. The type of visual output/display may includeLCD displays, LED displays, plasma displays, OLED displays and the like.The output/display 44 may also be an interactive or touch sensitivescreen 46 having an input device such as, for example, a touch screencomprising a capacitive screen or a resistive screen. The pump 12 mayadditionally include a keyboard or other input device known in the artfor data entry, which may be integrated with or separate from thedisplay. The output/display 44 of the pump 12 may also include acapability to operatively couple to a secondary display device such as alaptop computer, mobile communication device such as a smartphone orpersonal digital assistant (PDA) or the like. Further details regardingsuch pump devices can be found in U.S. Patent Application No.2011/0144586, which is incorporated herein by reference.

FIG. 2 illustrates a block diagram of some of the features that may beincorporated within the housing 26 of the pump 12. The pump 12 includesa processor 42 that functions to control the overall functions of thedevice. The infusion pump 12 may also include a memory device 30, atransmitter/receiver 32, an alarm 34, a speaker 36, a clock/timer 38, aninput device 40, the processor 42, a user interface suitable foraccepting input and commands from a user such as a caregiver or patient,a drive mechanism 48, and an estimator device 52. One embodiment of auser interface as shown in FIG. 2 is a graphical user interface (GUI) 60having a touch sensitive screen 46 with input capability. The memorydevice 30 may be coupled to the processor 42 to receive and store inputdata and to communicate that data to the processor 42. The input datamay include user input data and non-user/sensor input data. The inputdata from the memory device 30 may be used to generate therapeuticparameters for the infusion pump 12. The GUI 60 may be configured fordisplaying a request for the user to input data and for receiving userinput data in response to the request, and communicating that data tothe memory.

The processor 42 may communicate with and/or otherwise control the drivemechanism, output/display, memory, a transmitter/receiver and othercomponents. In some embodiments, the processor 42 may communicate with aprocessor of another device, for example, a continuous glucose monitor(CGM), through the transmitter/receiver. The processor 42 may includeprogramming that can be run to control the infusion of insulin or othermedicament from the cartridge, the data to be displayed by the display,the data to be transmitted via the transmitter, etc. The processor 42may also include programming that may allow the processor to receivesignals and/or other data from an input device, such as a sensor thatmay sense pressure, temperature, motion/activity or other parameters.The processor 42 may determine the capacity of the drug deliveryreservoir and/or the volume of fluid disposed in the drug deliveryreservoir and may set therapeutic parameters based on its determination.

The processor 42 may also include additional programming to allow theprocessor 42 to learn user preferences and/or user characteristicsand/or user history data. This information can be utilized to implementchanges in use, suggestions based on detected trends, such as, weightgain or loss. The processor can also include programming that allows thedevice to generate reports, such as reports based upon user history,compliance, trending, and/or other such data. Additionally, infusionpump device embodiments of the disclosure may include a “power off” or“suspend” function for suspending one or more functions of the device,such as, suspending a delivery protocol, and/or for powering off thedevice or the delivery mechanism thereof. For some embodiments, two ormore processors may be used for controller functions of the infusionpump devices, including a high power controller and a low powercontroller used to maintain programming and pumping functions in lowpower mode, in order to save battery life.

The memory device 30 may be any type of memory capable of storing dataand communicating that data to one or more other components of thedevice, such as the processor. The memory may be one or more of a Flashmemory, SRAM, ROM, DRAM, RAM, EPROM and dynamic storage, for example.For instance, the memory may be coupled to the processor and configuredto receive and store input data and/or store one or more template orgenerated delivery patterns. For example, the memory can be configuredto store one or more personalized (e.g., user defined) deliveryprofiles, such as a profile based on a user's selection and/or groupingof various input factors, past generated delivery profiles, recommendeddelivery profiles, one or more traditional delivery profiles, e.g.,square wave, dual wave, basal rate and bolus profiles, and/or the like.The memory can also store, for example, user information, history ofuse, glucose measurements, compliance and an accessible calendar ofevents.

The housing 26 of the pump 12 may be functionally associated with aninterchangeable and a removable glucose meter 20 and/or infusioncartridge 16. The infusion cartridge 16 may have an outlet port 54 thatmay be connected to an infusion set (not shown) via an infusion setconnector 18 or to an infusion and continuous glucose monitoring sensorcombination. Further details regarding some embodiments of variousinfusion pump devices can be found in U.S. Patent Application No.2011/0144586, which is hereby incorporated by reference.

Referring to FIG. 3 , a front view of the pump 12 is depicted. The pump12 may include a user interface, such as, for example, a user-friendlyGUI 60 on a front surface 58 or other convenient location of the pump12. The GUI 60 may include a touch-sensitive screen 46 that may beconfigured for displaying data, facilitating data entry by a patient,providing visual tutorials, as well as other interface features that maybe useful to the patient operating the pump 12. A bolus object 82 canalso be displayed on the screen 46.

FIG. 4 illustrates an embodiment of a bolus object 82, which may bedisplayed on the touch screen 46. The bolus object 82 may be a “softkey” such that when selected by the user the processor initiatesexecution of a bolus delivery program that allows a user to set up thedelivery of a bolus of medicament such as insulin. Furthermore, thebolus delivery program may include a bolus workflow or protocol whichmay, in combination with the processor 42 and memory 30 of the portableinfusion device 12, present the user with pages or screenrepresentations having one or more queries and/or information forsetting up an appropriate bolus of medicament such as insulin to bedelivered to the user.

In addition, once a bolus delivery has been setup, a bolus object 82 mayalso include a bolus status indicator 92 that provides feedback to theuser regarding the programmed bolus delivery of insulin. For example,the status indicator 92 may provide feedback as to how much of the bolushas been delivered to the user. The bolus status indicator 92 maydisplay the total bolus volume of insulin to be delivered (shown by wayof example as 0.7 units). The bolus status indicator may also provideanimated feedback, such as an animated indicator line 94 or bar thatmoves in a generally intuitive manner such that the status of the bolusdelivery is generally understood by the user. Furthermore, feedback maybe provided to a user for any number of reasons and may be portrayed toa user in various configurations, e.g., one or more blinking lights,color changes on the display 46, audible, tactile (e.g., vibratory)indications, etc.

For example, the animated indicator line 94 may travel from one side tothe other of the bolus status indicator 92 as the bolus is delivered tothe user. By way of further example, as the animated indicator line 94moves, the color on one side of the animated indicator line 94 may be adifferent color than the other side such that it is generally intuitiveto a user as to the status of the bolus delivery process. Therefore, thebolus status indicator 92 may provide efficient and user-friendlyinformation that is easily accessible for a user to view and understandthe status of insulin being delivered.

Infusion pump 12 may be configured to allow a user to set up a personaldelivery profile including a number of queries, confirmations, andopportunities for a user to view and modify information regarding adelivery profile. An exemplary delivery profile that allows a user tocustomize the delivery of medicament such as insulin, based on a numberof settings, over, e.g., a twenty-four hour period is described in U.S.Patent Application No. 2011/0144586.

Current infusion pumps typically allow for delivery of two infusiontypes—a basal rate and a bolus delivery. A basal rate typically deliversinsulin at a constant rate over an extended period of time and isprovided to maintain target glucose levels throughout the day when auser is not eating. Boluses are delivered to counteract carbohydratesconsumed at meal times to maintain target glucose levels. For a mealbolus, for example, the user may enter the amount of carbohydrates theuser is about to ingest and the user's carbohydrate ratio (the volume ofinsulin programmed to be delivered for every particular number ofcarbohydrates predicted to be consumed by the user). Based on thisinformation, the infusion pump will generate an estimate of a bolusamount of insulin to be delivered. If accepted by the user, e.g., byentering a command such as by depressing a button, touching an object ona touchscreen, etc., the then-current basal delivery mode is suspendedand the bolus delivery is initiated.

In some embodiments, one of the customizable insulin delivery parametersthat can be set in the personal delivery profile stored in the memory 30is a maximum bolus amount. In addition, the maximum bolus amount itselfmay have a maximum value to which the device will allow it to be set.The maximum bolus amount limits the size of a bolus that a user candeliver in order to prevent the user from inadvertently receiving abolus larger or much larger than is needed. Such a circumstance canarise as a result of, for example, a data entry or a typographical error(such as a user inadvertently requesting, e.g., a bolus of 44 units ofinsulin when meaning to program a delivery of a bolus of 4 units ofinsulin). The maximum bolus limit parameter, therefore, serves a safetyfunction by preventing the user from receiving an overly large andunsafe bolus of medicament such as insulin.

However, circumstances can arise that can lead either to a userregularly requiring a bolus of medicament such as insulin that is largerthan the pump's maximum allowed value or that is larger or much largerthan the user's typical requirements and therefore over the user's setlimit. To address such situations, pump 12 can in some embodiments beprovided with a maximum bolus override feature. Such a feature canprovide the safety benefits of preventing inadvertent intake of apotentially unsafe amount of insulin while allowing the flexibility totake a larger than normal dose if appropriate for the given situation.

FIG. 5 depicts a flowchart of a method for overriding a maximum bolus110 in an insulin pump according to an embodiment of the invention. Whenthe user programs or instructs delivery of a bolus of medicament thatexceeds the maximum bolus limit set on the device at step 112 a warningalerting the user that the maximum bolus limit has been exceeded can beissued at step 114 (see, e.g., FIG. 6 ). The warning can include one ormore of a visual alert displayed on the graphical user interface 60 andan audible or tactile alert. In one embodiment, a warning will be issuedonly if a maximum bolus override feature is turned on. Otherwise, thedevice will automatically not deliver the bolus and may alert the userthat no bolus is being delivered. If the user does not confirm orcancels the bolus at step 116, the bolus delivery is terminated at step126. If the user confirms the bolus, a first portion of the bolus isdelivered to the user at step 118. The bolus can automatically becancelled if the user does not respond to the warning within apredetermined amount of time. Alternatively, the first portion of thebolus can be automatically delivered if the user does not respond withinthe predetermined period of time.

In one embodiment, the first portion of the bolus is equal to themaximum bolus limit set on the device. In other embodiments, the firstportion can be another amount, such as a predetermined percentage of themaximum bolus or a predetermined percentage of the requested bolus (solong as the remaining bolus amount is not over the maximum limit). Infurther embodiments, the portion of the first bolus deliveredimmediately can be entered and/or adjusted by the user. These parameterscan be programmed into the device by the user, or alternatively, can bepreprogrammed into the device and modifiable by the user.

After the first portion of the bolus has been delivered, one or morereminders are displayed to the user at step 120 on the graphical userinterface 60, which in some embodiments can be accompanied by an audibleor tactile indication. In one embodiment, if a first reminder is notanswered additional reminders can be given at escalating volumes,vibration levels, etc. in case the user is not noticing the reminders.If the user does not confirm or cancels the second portion of the bolusafter the one or more reminders are given the bolus delivery isterminated at step 126. If the user does confirm the bolus, then at step124 the remaining, second portion of the bolus is delivered to the user.As with the initial warning, the second portion of the bolus can incertain embodiments either automatically be delivered or automaticallybe cancelled if the reminder is not confirmed or cancelled within apredetermined period of time.

For example, if a user programs a bolus of 40 units of insulin but themaximum bolus limit on the device is 25 units, a warning screen 130 maybe shown on the touch screen 46 of the graphical user interface 60 asshown in FIG. 6 . The warning screen 130 can display a warning message132 indicating that that maximum bolus limit has been exceeded andpresent the user with a selectable cancel object 134 and a selectableconfirm object 136 to cancel or confirm the bolus delivery. If the userconfirms delivery, as noted above a first portion of the requested bolusis delivered, such as the 25 units that is the maximum limit. Followingdelivery of the 25 units, the graphical user interface 60 will thendisplay a reminder message 138 such as shown in FIG. 7 . The remindermessage 138 can identify the number of units delivered as well as thenumber of additional units requested. A cancel object 134 and a confirmobject 136 provide the user with the ability to cancel or confirm theremaining insulin.

Thus, a maximum bolus override procedure as described herein providesflexibility to the user while preserving the safety benefits of themaximum bolus feature. Because the procedure requires the user toconfirm the requested bolus initially and may also require a secondconfirmation to deliver additional units in a second portion of thebolus, the user is precluded from inadvertently taking an overly largebolus due to a typographical error or other mistake. However, theoverride confirmation provides the ability to deviate from the standardlimits that may unduly restrict the delivery of boluses when largeamounts are in fact warranted.

With regard to the above detailed description, like reference numeralsused therein may refer to like elements that may have the same orsimilar dimensions, materials, and configurations. While particularforms of embodiments have been illustrated and described, it will beapparent that various modifications can be made without departing fromthe spirit and scope of the embodiments herein. Accordingly, it is notintended that the invention be limited by the forgoing detaileddescription.

The entirety of each patent, patent application, publication, anddocument referenced herein is hereby incorporated by reference. Citationof the above patents, patent applications, publications and documents isnot an admission that any of the foregoing is pertinent prior art, nordoes it constitute any admission as to the contents or date of thesedocuments.

Modifications may be made to the foregoing embodiments without departingfrom the basic aspects of the technology. Although the technology mayhave been described in substantial detail with reference to one or morespecific embodiments, changes may be made to the embodimentsspecifically disclosed in this application, yet these modifications andimprovements are within the scope and spirit of the technology. Thetechnology illustratively described herein may suitably be practiced inthe absence of any element(s) not specifically disclosed herein. Theterms and expressions which have been employed are used as terms ofdescription and not of limitation and use of such terms and expressionsdo not exclude any equivalents of the features shown and described orportions thereof and various modifications are possible within the scopeof the technology claimed. Although the present technology has beenspecifically disclosed by representative embodiments and optionalfeatures, modification and variation of the concepts herein disclosedmay be made, and such modifications and variations may be consideredwithin the scope of this technology.

1. An ambulatory infusion pump, comprising: a delivery mechanism adaptedto facilitate delivery of insulin to a user; a user interface adapted todisplay operating parameters of the delivery mechanism and to receiveinput data from a user; a memory adapted to store a maximum bolus limitdefining a maximum bolus amount a user is allowed to enter into the userinterface for delivery by the delivery mechanism; and a processoroperably connected to the delivery mechanism, user interface and memory,the processor adapted to execute a maximum bolus override procedure wheninput data from the user requests a bolus amount greater than themaximum bolus amount, the maximum bolus override procedure comprising:providing an alert indicating that the bolus amount in the requestexceeds the maximum bolus limit; receiving a confirmation of the requestin response to the alert; and causing the delivery mechanism to deliverthe bolus amount to the user in response to the confirmation.
 2. Theambulatory infusion pump of claim 1, wherein causing the deliverymechanism to deliver the bolus amount in response to the confirmationcomprises delivering a first portion of the bolus amount and the maximumbolus override procedure the processor is adapted to execute furthercomprises: after the first portion of the bolus amount is delivered tothe user, providing a reminder that a second portion of the bolus amountcomprising a remainder of the bolus amount was requested; receiving asecond confirmation to deliver the second portion of the bolus amount;and causing the delivery mechanism to deliver the second portion of thebolus amount to the user in response to the second confirmation.
 3. Theambulatory infusion pump of claim 2, wherein the first portion of thebolus amount is equal to the maximum bolus amount.
 4. The ambulatoryinfusion pump of claim 2, wherein the first portion of the bolus amountis a predetermined percentage of the bolus amount.
 5. The ambulatoryinfusion pump of claim 1, wherein the user interface is adapted toenable the user to set the maximum bolus limit.
 6. The ambulatoryinfusion pump of claim 5, wherein the memory stores a maximum limit forthe maximum bolus amount, and the processor is further adapted toinhibit the user from setting the maximum bolus amount above the maximumlimit.
 7. The ambulatory infusion pump of claim 2, wherein the firstportion of the bolus amount is not delivered if the confirmation is notreceived within a predetermined period of time.
 8. The ambulatoryinfusion pump of claim 2, wherein the first portion of the bolus isautomatically delivered if the confirmation is not received within apredetermined period of time.
 9. The ambulatory infusion pump of claim2, wherein the second portion of the bolus is not delivered if thesecond confirmation is not received within a predetermined period oftime.
 10. The ambulatory infusion pump of claim 1, wherein the alert isdisplayed on the user interface.
 11. The ambulatory infusion pump ofclaim 10, wherein the alert further includes at least one of an audioand a tactile alert.
 12. The ambulatory infusion pump of claim 1,wherein the user interface is a graphical user interface.
 13. Anambulatory infusion pump, comprising: a delivery mechanism adapted tofacilitate delivery of insulin to a user; a user interface adapted todisplay operating parameters of the delivery mechanism and to receiveinput data from a user; a memory adapted to store a maximum bolus limitdefining a maximum bolus amount a user is allowed to enter into the userinterface for delivery by the delivery mechanism; and a processoroperably connected to the delivery mechanism, user interface and memory,the processor adapted to execute a maximum bolus override procedure wheninput data from the user requests a bolus amount greater than themaximum bolus amount, the maximum bolus override procedure comprising:providing an alert on the user interface indicating that the bolusamount in the request exceeds the maximum bolus limit; receiving aconfirmation of the request in response to the alert through the userinterface; causing the delivery mechanism to deliver a first portion ofthe bolus amount to the user in response to the confirmation; after thefirst portion of the bolus amount is delivered to the user, providing areminder on the user interface that a second portion of the bolus amountcomprising a remainder of the bolus amount was requested; receiving asecond confirmation through the user interface to deliver the secondportion of the bolus amount; and causing the delivery mechanism todeliver the second portion of the bolus amount to the user in responseto the second confirmation.
 14. The ambulatory infusion pump of claim13, wherein the first portion of the bolus amount is equal to themaximum bolus amount.
 15. The ambulatory infusion pump of claim 13,wherein the first portion of the bolus amount is a predeterminedpercentage of the bolus amount.
 16. The ambulatory infusion pump ofclaim 13, wherein the graphical user interface is adapted to permit theuser to set the maximum bolus limit.
 17. The ambulatory infusion pump ofclaim 16, wherein the memory stores a maximum limit for the maximumbolus amount, and the processor is further adapted to inhibit the userfrom setting the maximum bolus amount above the maximum limit.
 18. Theambulatory infusion pump of claim 13, wherein the alert and the remindereach further include at least one of an audio and a tactile alert. 19.The ambulatory infusion pump of claim 13, wherein the user interface isa graphical user interface.
 20. A method of overriding a maximum boluslimit in an ambulatory infusion pump, comprising: storing a maximumbolus limit defining a maximum bolus amount a user is allowed to enterinto a user interface of the infusion pump for delivery by a deliverymechanism of the ambulatory infusion pump; receiving input data from theuser interface requesting a bolus amount greater than the maximum bolusamount; providing an alert indicating that the bolus amount in therequest exceeds the maximum bolus limit; receiving a confirmation of therequest in response to the alert; and causing the delivery mechanism todeliver the bolus amount to the user in response to the confirmation.